Expanded Access Protocol of Troriluzole in Patients With Spinocerebellar Ataxia (SCA)

Last updated: November 1, 2024
Sponsor: Biohaven Pharmaceuticals, Inc.
Overall Status: Planned

Phase

N/A

Condition

Friedreich's Ataxia

Dyskinesias

Spinocerebellar Disorders

Treatment

Troriluzole

Clinical Study ID

NCT06034886
BHV4157-401
  • Ages > 18
  • All Genders

Study Summary

The purpose of this expanded access protocol is to provide access to the investigational drug troriluzole in patients with spinocerebellar ataxia (SCA).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Patient has a confirmed diagnosis of Spinocerebellar Ataxia (SCA), defined as eitherclinical evidence supporting diagnosis OR confirmed genotypic diagnosis.

  • Adequate hepatic function.

Exclusion

Key Exclusion Criteria:

  • Patient is known to have acute or chronic liver disease that is clinicallysignificant in the judgement of the Physician.

  • Patient has a history of a clinically significant medical condition that wouldinterfere with the patients ability to comply with the expanded access protocol orwould place the patient at increased risk.

Study Design

Treatment Group(s): 1
Primary Treatment: Troriluzole
Phase:
Study Start date:
Estimated Completion Date:

Study Description

This is an Intermediate-Size Patient Population Expanded Access Protocol designed to provide treatment use of troriluzole to patients with spinocerebellar ataxia (SCA) who are considered to be eligible in the clinical judgement of the Investigator/treating physician. The population includes both troriluzole naive patients and patients participating in previous clinical trials with troriluzole (BHV4157-201 and BHV4157-206) who have a confirmed diagnosis of spinocerebellar ataxia.